Dual Lumen Transcerivical Intrauterine Kit
FDA 510(k) K920044 · Telos Medical Corp.
510(k) numberK920044
Submission
- Device name
- Dual Lumen Transcerivical Intrauterine Kit
- Applicant
- Telos Medical Corp.
Keene, CA, US - Received
- January 6, 1992
- Decision date
- April 3, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KXO – Monitor, Pressure, Intrauterine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2700
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code KXO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K991235 | Softrans Temp Intrauterine Pressure Catheter System (Iup 5000, Softrans Temp Iupc)KXO · Traditional | Ludlow Technical Products | 07/08/1999SE |
| K982565 | Easy Trans TipKXO · Traditional | Carl Schuh | 09/22/1998SE |
| K974730 | Softrans Plus Intrauterine Pressure Catheter System (Iup 5000, Softrans Plus Iupc)KXO · Traditional | Graphic Controls Corp. | 07/14/1998SE |
| K964279 | Softrans Intrauterine Pressure Catheter System (Iup 4000 Softrans Iupc)KXO · Traditional | Graphic Controls Corp. | 01/22/1997SE |
| K961290 | Iup - Tip Trans, Iup - Proxi TransKXO · Traditional | Scientific Device Manufacturer, LLC | 10/15/1996SE |
| K950498 | Life Trace Trans Tip Intrauterine Pressure CatheterKXO · Traditional | Graphic Controls Corp. | 07/24/1995SE |
| K950708 | Lifetrace Intrauterine Pressure Catheter Iup 3000KXO · Traditional | Graphic Controls Corp. | 05/25/1995SE |
| K922323 | MX4042/MC4044 Series Simulcath(Tm)KXO · Traditional | Medex, Inc. | 06/14/1994SE |
| K910742 | Medi-Trace Disposable Intrauterine CatheterKXO · Traditional | Graphic Controls Corp. | 01/14/1992SE |
| K905563 | Intran PlusKXO · Traditional | Utah Medical Products, Inc. | 06/19/1991SE |
More from Utah Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K920375 | Disposable Intrauterine Pressure TransducerHFN · Traditional | 10/27/1992SE |
| K914387 | Transcervical Intrauterine KitHGS · Traditional | 12/30/1991SE |
| K905018 | Lab-Site Safety NeedleDQO · Traditional | 01/16/1991SE |
| K905017 | Lab-SiteDQO · Traditional | 01/15/1991SE |
| K882224 | Ultrans Disposable IntrauterineHFN · Traditional | 10/12/1989SE |
| K883832 | Catheter, Intrauterine and IntroducerKXO · Traditional | 12/13/1988SE |
Questions and answers
When was Dual Lumen Transcerivical Intrauterine Kit cleared by the FDA?
Dual Lumen Transcerivical Intrauterine Kit (K920044) received a 510(k) decision of Substantially Equivalent on April 3, 1992, 88 days after the submission was received.
What is the product code of K920044?
The FDA product code is KXO – Monitor, Pressure, Intrauterine, a Class II (moderate risk) device regulated under 21 CFR 884.2700.